Replies to post #272896 on NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

Thank you for posting these comments to the FDA from NWBO.

[eagle8]

Thank you !

[exwannabe]

Now that is funny. I can just see the PR:

"Red haired patients had a 37% survival at 53 months in the treatment arm compared to 14% in control (P<.2)"

There is a reason why subgroups are generally BS. Take enough different subsets and one will look good by random chance. Especially if you do not even care about stat sig.

When the FDA releases the guidance (probably late this year or early next) I would not be surprised to see them comment on this.

[BWIS]

Typo in 5th paragraph.

Reading this doesn't give me a warm fuzzy on statistical significance.

Maybe she's just sandbagging to trap the shorts right?

LOL. Oh well.

And the beat goes on.

[Whitewater55]

Thanks for sharing. I’m unable to view on my iPhone. Any takeaway you can share while I wait to view on my computer? TIA

[Doc logic]

conservative123,

Thank you for posting this. Unfortunately, in my view, this comment makes Linda look desperate for a guaranteed pathway for approval outside of current norms. Some of her reasons for this I believe are legit as flipper44 and I were both agreed that ICT-107 from IMUC should have been made available to patients in the appropriate subgroup of patients found to be responding even though small. I believe NWBO has at a minimum a pathway to approval at this point but perhaps they feel it is not guaranteed and should be. I also believe that there is an underlying value to combos with checkpoint inhibitors and Direct that the market has not taken into consideration. Best wishes.

[marzan]

Thanks conservative. I got it. Umibe/iwasadiver, I got it. Please ignore my request.

[marzan]

I like LP's suggestion to approving the subgroup and I see collecting post marketing data to keep the approval is very reasonable. In fact FDA has adopted this practice in some instances in the past. In our trial, the statistical strength is vulnerable to getting muddied because of the crossover design went effective such that only 10% remained in the placebo. But we may not be surprised when we unblind to see the crossover patients who came from placebo might have already been evented out and the ones alive today are all from the treatment arm. In that case, all our problems are solved even if FDA did not adopt our subgroup suggestion in the final guidance. While our trial is still unblinded, I see LP's suggestion is protective for us. Overall, FDA is going to allow us comparing the efficacy with historical controls which is what is very good for us because I think FDA realizes crossover design in trials like ours do kill the statistical strength. Hope LP et al release flurry of good news between now and ASM. I think 30% minimum are still alive which is like 60 patients for a minimum of 4 years. I bet they are all from the treatment arm. This OS rate is unprecedented in GBM.